JMIR Publications

ABSTRACT

BACKGROUND: Chronic heart failure (CHF), characterized by high rates of mortality, re-hospitalization, and prevalence, represents a major global disease burden. Patients with CHF frequently experience reduced exercise tolerance, and there is currently a lack of effective pharmacological interventions specifically proven to improve both clinical symptoms and exercise tolerance in this population. Although Yiqi Fumai lyophilized injection (YQFM) is recommended by Chinese guidelines as a representative therapy for CHF and has demonstrated notable benefits in alleviating symptoms and enhancing quality of life, high-quality evidence to guide clinical decision-making regarding its impact on exercise tolerance remains limited. Therefore, this study aims to provide clinical evidence that YQFM can improve exercise tolerance in patients with CHF, thereby contributing to advances in CHF prevention and treatment. METHODS: The clinical effects of YQFM to increase exercise tolerance in patients with CHF were evaluated in this prospective cohort study. The YQFM group (n=128) and the non-YQFM group (n=64) were split in a 1:2 ratio among the 192 CHF patients who satisfied the inclusion and exclusion criteria. The YQFM group received Guideline-Directed Medical Therapy (GDMT) loaded with YQFM for 10 days of exposure, with follow-up at weeks 4, 8, and 12 after exposure, while the non-YQFM group received standardized therapy with GDMT. The Veterans Specific Activity Questionnaire (VSAQ) served as the primary evaluation index, while the Chinese Medicine Symptom Score Scale, the NYHA cardiac function classification, the BNP or NT-proBNP, the 6-minute walk test (6MWT), the Kansas City Cardiomyopathy Patient Quality of Life Scale (KCCQ), and the Echocardiogram were used as secondary evaluation indexes. DISCUSSION: In order to improve prevention and treatment strategies for chronic heart failure, this study aimed to provide an objective and scientific evaluation of the clinical effects of YQFM intervention on exercise tolerance in patients with chronic heart failure. TRIAL REGISTRATION: This trial was registered in the International Traditional Medicine Clinical Trial Registry Platform (http://itmctr.ccebtcm.org.cn/) on October 12, 2024 (No. ITMCTR2024000541).